The REC-CAGEFREE I randomized trial compared drug-coated balloon (DCB) angioplasty with stenting as the initial strategy for de novo coronary artery stenoses. The results showed that DCB with rescue use of drug-eluting stents (DES) led to a significantly higher rate of adverse cardiovascular events compared to intended stenting. This study, presented by Ling Tao, MD, PhD, at the European Society of Cardiology (ESC) meeting and published in The Lancet, raised important questions about the efficacy of DCB angioplasty in this population.
The primary finding of the study was that the composite 24-month rate of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization was nearly doubled in the DCB group compared to the stenting group. This difference was primarily driven by the need for target lesion revascularization, especially in patients with non-small vessel disease. These results suggest that DES implantation should remain the preferred treatment strategy for de novo coronary artery stenoses.
Ling Tao highlighted the need to identify lesion types that could be treated effectively without stenting, such as bifurcation lesions or those with fibrosis. She also suggested exploring DCB technologies that deliver a more sustained drug dose to prevent late events. The ongoing follow-up of patients for 10 years will help determine whether the higher rate of revascularization in the DCB group translates into significant clinical outcomes.
The trial included 2,272 adults at 43 sites in China and focused on patients with non-complex coronary artery disease. The study population was entirely of Chinese ethnicity and predominantly male. The use of paclitaxel-coated balloon angioplasty with optional rescue stenting was compared to the deployment of a second-generation sirolimus-eluting stent. However, neither device used in the study is FDA approved, and the generalizability of the findings to other populations remains uncertain.
The REC-CAGEFREE I trial provides valuable insights into the efficacy of DCB angioplasty compared to stenting for de novo coronary artery stenoses. The results suggest that DES implantation should continue to be the preferred treatment strategy in this patient population. Further research is needed to explore the potential benefits of DCB technologies and to determine the long-term clinical impact of revascularization rates in this population.
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